Real-world experience with cabazitaxel in patients with metastatic castration-resistant prostate cancer: a final, pooled analysis of the compassionate use programme and early access programme

Abstract

// Zafar Malik 1 , Axel Heidenreich 1 , 2 , Sergio Bracarda 3 , Alexandros Ardavanis 4 , Philip Parente 5 , Hans-Joerg Scholz 6 , Ayse Ozatilgan 7 , Evelyne Ecstein-Fraisse 8 , Simon Hitier 9 and Giuseppe Di Lorenzo 10 1 The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, UK 2 Department of Urology, Uro-Oncology, Robot-Assisted and Specialized Urologic Surgery, University Hospital Cologne, Cologne, Germany 3 Azienda USL Toscana Sud-Est, Istituto Toscana Tumori (ITT), Ospedale San Donato, Arezzo, Italy 4 Oncology Hospital AGIOS SAVVAS Oncology Clinic, Athens, Greece 5 ECRU-Oncology, Victoria, Australia 6 Asklepios Klink GmbH Weissenfels, Weissenfels, Germany 7 Sanofi, Cambridge, Massachusetts, USA 8 Sanofi, Paris, France 9 Sanofi, Chilly-Mazarin, France 10 Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy Correspondence to: Zafar Malik, email: [email protected] Keywords: mCRPC; cabazitaxel; CUP; EAP; real-world Received: January 08, 2019     Accepted: April 29, 2019     Published: June 25, 2019 ABSTRACT Background Cabazitaxel is a second-generation taxane approved for use in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel. Early access programmes were established to allow eligible patients with mCRPC access to cabazitaxel before regulatory approval. Materials and Methods The primary objective was to allow access to cabazitaxel before commercial availability for patients with mCRPC whose disease had progressed during or after chemotherapy with docetaxel; the secondary objective was overall safety. Patients received cabazitaxel 25 mg/m 2 on Day 1 of a 21-day cycle, with daily oral 10 mg prednisone/prednisolone. G-CSF was administered per ASCO guidelines. Results In total, 1432 patients received cabazitaxel across 41 countries between 2010 and 2014 (median 6.0 treatment cycles [range 1–49]). The most frequently occurring treatment-emergent adverse events (TEAEs) possibly related to treatment were diarrhoea (33.3%), fatigue (25.4%) and anaemia (23.7%); the most frequently occurring possibly related Grade 3/4 TEAEs were neutropenia (18.7%) and febrile neutropenia (6.9%). G-CSF was administered in ≥ 1 cycle in 64% of patients (10.1% therapeutic use; 57.8% prophylactic use; 9.7% both uses). Conclusion The safety profile of cabazitaxel in this pooled analysis of two cabazitaxel early access programmes was manageable and consistent with previous Phase III trials (TROPIC, PROSELICA).